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Dosage in Patients Naïve to Levodopa Therapy

The recommended starting dosage of RYTARY in levodopa-naïve patients is 23.75 mg / 95 mg taken orally three times a day for the first 3 days. On the fourth day of treatment, the dosage of RYTARY may be increased to 36.25 mg / 145 mg taken three times a day.

Based upon individual patient clinical response and tolerability, the RYTARY dose may be increased up to a maximum recommended dose of 97.5 mg / 390 mg taken three times a day. The dosing frequency may be changed from three times a day to a maximum of five times a day if more frequent dosing is needed and if tolerated. The maximum recommended daily dose of RYTARY is 612.5 mg / 2450 mg.

Maintain patients on the lowest dosage required to achieve symptomatic control and to minimize adverse reactions such as dyskinesia and nausea.

Converting from Immediate-Release Carbidopa-Levodopa to RYTARY

To convert patients from immediate-release carbidopa-levodopa to RYTARY, determine the recommended starting dosage of RYTARY using Table 1.

The dosages of other carbidopa and levodopa products are not interchangeable with the dosages of RYTARY.

Adjust the dose to maintain patient tolerance and sufficient symptomatic control. The dosing frequency may be changed from three times a day to a maximum of five times a day if more frequent dosing is needed and if tolerated. The maximum recommended daily dose of RYTARY is 612.5 mg / 2450 mg.

For patients currently treated with carbidopa and levodopa plus catechol-O-methyl transferase (COMT) inhibitors (such as entacapone), the initial total daily dose of levodopa in RYTARY described in Table 1 may need to be increased.

Use of RYTARY in combination with other levodopa products has not been studied.

Discontinuation of RYTARY

Avoid sudden discontinuation or rapid dose reduction of RYTARY. The daily dose of RYTARY should be tapered at the time of treatment discontinuation [see Warnings and Precautions (5.2)].

Administration Information

Swallow RYTARY whole with or without food. A high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours [see Clinical Pharmacology (12.3)].

Do not chew, divide or crush RYTARY capsules. For patients who have difficulty swallowing intact capsules, administer RYTARY by carefully opening the capsule, sprinkling the entire contents on a small amount of applesauce (1 to 2 tablespoons), and consuming immediately. Do not store the drug/food mixture for future use.